Effect of Compound (Cardiol Forte) on Lipid And Glycemic Parameters in Low Cardiovascular Risk Individuals

NCT07515573 | Not Yet Recruiting

• 1 other identifier: CLARISKI_RCT2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effects of a combination dietary supplement, Cardiol Forte, on lipid and glycemic parameters in adults at low cardiovascular risk with suboptimal cholesterol levels. After a 14- to 28-day run-in period with standardized dietary and behavioral instructions, 50 participants will be randomized in a 1:1 ratio to receive either Cardiol Forte or matching placebo for 8 weeks under double-blind conditions. After completion of the double-blind phase, all participants will receive Cardiol Forte for an additional 8 weeks in an open-label extension. The primary objective is to compare the change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 8 between Cardiol Forte and placebo. Secondary objectives include evaluation of other lipid parameters, fasting plasma glucose, Omega-3 Index, selected inflammatory and liver-related markers, and endothelial reactivity.

Conditions

Dyslipidemia

Keywords

Cardiol Forte; Dyslipidemia; non-HDL cholesterol; Glycemic profile; Cardiovascular prevention; Low cardiovascular risk; Eicosapentaenoic acid; EPA; Docosahexaenoic acid; DHA; Artichoke; Bergamot; Hydroxytyrosol; Coenzyme Q10; Folic acid; Vitamin E

Outcome Measures

Primary Outcomes (1)

• Change from baseline in plasma non-high-density lipoprotein cholesterol (non-HDL-C)

  Between-group comparison of the change from baseline in plasma non-HDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).

  Baseline to Week 8 (Day 56 ± 3 days)

Secondary Outcomes (17)

• Change from baseline in total cholesterol (TC)

  Baseline to Week 8 (Day 56 ± 3 days)

• Change from baseline in low-density lipoprotein cholesterol (LDL-C)

  Baseline to Week 8 (Day 56 ± 3 days)

• Change from baseline in triglycerides (TG)

  Baseline to Week 8 (Day 56 ± 3 days)

• Change from baseline in high-density lipoprotein cholesterol (HDL-C)

  Baseline to Week 8 (Day 56 ± 3 days)

• Change from baseline in very-low-density lipoprotein cholesterol (VLDL-C)

  Baseline to Week 8 (Day 56 ± 3 days)

Other Outcomes (17)

• Change from Week 8 to Week 16 in total cholesterol (TC)

  Week 8 to Week 16 (Day 56 ± 3 days to Day 112 ± 3 days)

• Change from Week 8 to Week 16 in low-density lipoprotein cholesterol (LDL-C)

  Week 8 to Week 16 (Day 56 ± 3 days to Day 112 ± 3 days)

• Change from Week 8 to Week 16 in triglycerides (TG)

  Week 8 to Week 16 (Day 56 ± 3 days to Day 112 ± 3 days)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Weeks 0-8: double-blind phase; placebo, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily.

Dietary Supplement: Cardiol Forte; Other: Placebo

Dietary supplement - Cardiol Forte

EXPERIMENTAL

Weeks 0-8: double-blind phase; Cardiol Forte, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily.

Dietary Supplement: Cardiol Forte

Interventions

Cardiol Forte DIETARY_SUPPLEMENT

Each capsule of Cardiol Forte contains fish oil 5025 TG 550.488 mg, corresponding to total omega-3 fatty acids 456 mg, of which eicosapentaenoic acid (EPA) 275 mg and docosahexaenoic acid (DHA) 137 mg; artichoke extract leaves (Altilix®) 150 mg; Citrus bergamia Risso et Poit. dry extract (BPF®) 100 mg; Cynara scolymus L. dry extract 10 mg; olive fruit dry extract standardized to 9% hydroxytyrosol 55.600 mg, corresponding to hydroxytyrosol 5.004 mg; coenzyme Q10 10 mg; folic acid 0.3 mg; and vitamin E 12 mg.

Dietary supplement - Cardiol Forte; Placebo

Placebo OTHER

Matching placebo soft capsules are identical to Cardiol Forte in appearance, odour, and taste and contain no active ingredients.

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 to 79 years
• Individuals in primary cardiovascular prevention
• Estimated 10-year cardiovascular risk \<10%
• Screening non-HDL-C between 140 and 220 mg/dL, or screening LDL-C between 110 and 190 mg/dL
• Ability to communicate adequately, to be understood, and to comply with the study requirements
• Willingness to participate in the study and provision of written, signed, and dated informed consent

You may not qualify if:

• Triglycerides \>400 mg/dL at screening
• Type 1 or type 2 diabetes mellitus
• Body mass index \>35 kg/m²
• Current treatment with lipid-lowering drugs or use of dietary supplements active on lipid metabolism
• Antihypertensive treatment not stabilized for at least 3 months
• Known clinically significant alterations of thyroid, hepatic, and/or renal function
• Women of childbearing potential not using adequate contraceptive methods
• Pregnancy or breastfeeding
• Any medical or surgical condition that, in the investigator's judgment, could make adherence to the protocol difficult or inconsistent, compromise participant safety, or interfere with study completion
• Known intolerance or hypersensitivity to any component of the study products

Sponsors & Collaborators

• U.G.A. Nutraceuticals: lead

Study Sites (1)

Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy

Bologna, BO, 40100, Italy

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Arrigo Francesco Giuseppe Cicero, MD, PhD

CONTACT

+39051214290; arrigo.cicero@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Phase 1 (Weeks 0 to 8) is quadruple-masked (participant, care provider, investigator, outcomes assessor). Phase 2 (Weeks 8 to 16) is an open-label extension in which all participants receive Cardiol Forte; therefore, no masking applies during Phase 2.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): May 4, 2028
• Study Completion (Estimated): May 4, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)